# K955630: Rna Medical Hemat Control

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Mar 1, 1996 after 81 days
- Product code: JJR (Electrolyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K151978: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (2016), 0 descendants of its own
- K121467: Eurotrol Hematocrit Control (2013), 0 descendants of its own
- K021924: Medica Easyqc Hematocrit Control (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K955630
Methodology: https://510kreport.com/methodology